Launch of New Ready-to-Use TPN for Preterm Newborns

The announcement was made during the 38th ESPEN (The European Society for Clinical Nutrition and Metabolism) Congress in Copenhagen, Sept. 17-20, with recognition that the first preterm patients have received PN therapy on NUMETA G13E in Sweden.

NUMETA G13E is indicated for PN administration in preterm newborn infants when oral or enteral nutrition is not possible, insufficient or contraindicated. NUMETA G13E addresses an important medical need to support preterm neonatal patients who have acute nutritional requirements by providing a balanced formulation of amino acids (protein), glucose (carbohydrates), lipids (fats) and electrolytes in a triple-chamber system that was pioneered by Baxter.

''Baxter’s NUMETA G13E is a well-balanced, ready-to-use formula in a triple-chamber system that simplifies the preparation process for healthcare workers and helps reduce the potential risk to patients of infection and dosing errors,'' said Brik Eyre, president of Baxter's Hospital Products business. ''NUMETA G13E is truly innovative nutritional therapy for preterm babies – among the most susceptible patients – when time and safety are critical factors to their care.''

NUMETA G13E is designed for activation and administration at the bedside. Research indicates ready-to-use PN may reduce the potential risk of medication errors and associated infections.² NUMETA G13E was reformulated to meet the current pediatric nutritional guidelines developed by the European Society for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) and ESPEN.

Baxter’s NUMETA G13E has Marketing Authorization from the Competent Authorities in 15 Western European countries, including Austria, Belgium, France, Germany, Ireland, Malta Netherlands, Poland, Switzerland, the U.K., and the Nordics where the launch initiated. Baxter plans to continue pursuing regulatory approvals and launching NUMETA G13E globally, including in additional European countries and Latin America in 2017.

Baxter offers additional pediatric triple-chamber PN solutions in Europe and select Latin American countries, including NUMETA G16E 500mL for term infants and toddlers (term infants through two years of age); and NUMETA G19E 1,000mL for children and adolescents (2-18 years of age).

Important Risk Information

The general contraindications for administering NUMETA as an activated two-chamber container system (with the lipid chamber inactivated for intravenous infusion) are as follows: hypersensitivity to egg, soy or peanut proteins, or to any of the active substances, excipients or components of the container; congenital abnormality of the amino acid metabolism; pathologically elevated plasma concentrations of sodium, potassium, magnesium, calcium and/or phosphorous; severe hyperglycemia; and concomitant treatment with ceftriaxone in newborns (<= 28 days of age), even if separate infusion lines are used.

The addition of lipids (administering NUMETA as an activated three-chamber container system for intravenous emulsion) is contraindicated in the following additional clinical situations: severe hyperlipidemia and severe disorders of lipid metabolism characterized by hypertriglyceridemia. Refer to the NUMETA product label for full prescribing information.

¹ Koletzko B, Goulet O, Hunt J, et al. ESPGHAN / ESPEN Guidelines on Paediatric Parenteral Nutrition. JPGN. 2005.

² Riskin A, Shiff Y, Shamir R. Parenteral Nutrition in Neonatology – To Standardize or Individualize? IMAJ 2006;8:641-645.

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